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Aichek
EUDAMEDClass IVD General (EU MDR)
Ref TT4706-AE10Y, TT4706-AE10N, TT4706-AE20Y, TT4706-AE20N
Identity
- Trade Name
- Aichek EUDAMEDT4 Total Thyroxine (CLIA) EUDAMED
- Device Name
- T4 Total Thyroxine (CLIA) EUDAMED
- Model / Reference
- TT4706-AE10Y, TT4706-AE10N, TT4706-AE20Y, TT4706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TT4706-AEZC EUDAMED
- Basic UDI-DI
- B-TT4706-AEZC EUDAMED
- EMDN Code
- W01020407 THYROXINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Aichek by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-TT4706-AEZC | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED 14d04342-c290-4cd7-a8a4-e1dbd2b5d67b 61 fields · synced Jul 12, 2026
- EUDAMED 4ad1ba60-8c03-4026-a44e-32afd4582baf-1 61 fields · synced Jul 12, 2026
- EUDAMED 4ad1ba60-8c03-4026-a44e-32afd4582baf-2 61 fields · synced Jul 12, 2026